THE MINISTRY OF AGRICULTURE, FISHERIES AND RURAL …extwprlegs1.fao.org/docs/pdf/cro140370.pdf ·...

THE MINISTRY OF AGRICULTURE, FISHERIES AND RURAL

DEVELOPMENT Pursuant to Article 15, paragraph 1, subparagraph 2 of the Food Act (Official Gazette 46/07) and Article 87, paragraph 6 of the Veterinary Act (Official Gazette 41/07), the Minister of Agriculture, Fisheries and Rural Development hereby issues the

ORDINANCE ON MAXIMUM RESIDUE LIMITS OF VETERINARY MEDICINAL

PRODUCTS IN FOODSTUFFS OF ANIMAL ORIGIN 1

Article 1

1) This Ordinance lays down the maximum residue limits of veterinary medicinal products (hereinafter: VMP) in foodstuffs of animal origin. (2) This Ordinance shall not apply to active principles of biological origin intended to produce active or passive immunity or to diagnose a state of immunity used in immunological VMPs. (3) This Ordinance shall not prejudice the application of special regulations prohibiting the use in livestock farming of certain substances having a hormonal action nor shall it prejudice the measures taken to prevent the unauthorised use of VMPs.

Definitions

Article 2 1) For the purposes of this Ordinance, the following definitions shall apply: (a) ‘residues of veterinary medicinal products’ means all pharmacologically active substances, whether active principles, excipients or degradation products, and their metabolites which remain in foodstuffs obtained from animals to which the VMP in question has been administered; b) ‘maximum residue limit’ (hereinafter: MRL) means the maximum concentration of residue resulting from the use of a VMP (expressed in mg/kg or µg/kg on a fresh weight basis) which may be legally permitted or recognised as acceptable in or on a food. MRL is based on the type and amount of residue considered to be without any toxicological hazard for human health as expressed by the acceptable daily intake, or on the basis of a temporary acceptable daily intake that utilises an additional safety factor. It also takes into account other relevant public health risks as well as food technology (food production) aspects. When establishing a MRL, consideration is also given to residues

that occur in food of plant origin and/or come from the environment. Furthermore, the MRL may be reduced to be consistent with good practices in the use of VMPs and to the extent that practical analytical methods are available.

Article 3 The list of pharmacologically active substances used in VMPs in respect of which MRLs have been established is contained in Annex I to this Ordinance.

Article 4 The list of pharmacologically active substances used in VMP in respect of which it is considered that it is not necessary for the protection of public health to establish a MRL are contained in Annex II to this Ordinance.

Article 5 The list of pharmacologically active substances used in VMPs in respect of which provisional MRLs have been established is contained in Annex III to this Ordinance.

Article 6 (1) The list of pharmacologically active substances used in VMPs in respect of which MRLs cannot be established because residues of the substances concerned, at whatever limit, in foodstuffs of animal origin constitute a hazard to the health of the consumer is contained in Annex II to this Ordinance. (2) The administration of the substances referred to in paragraph 1 of this Article to food-producing animals shall be prohibited.

Article 7 (1) In order to obtain the inclusion in Annexes I, II or III to this Ordinance of a pharmacologically active substance which is intended for use in VMPs for administration to food-producing animals, an application to establish a MRL shall be submitted to the European Agency for the Evaluation of Medicinal Products. (2) The application referred to in paragraph 1 of this Article shall contain the information and particulars referred to in Annex V to this Ordinance.

Article 8 The import of foodstuffs of animal origin shall be permitted if the level of residue does not exceed the MRL laid down in Annexes I or III to this Ordinance or if it contains the substance listed in Annex II to this Ordinance.

Article 9

Where a competent authority, as a result of new information or a reassessment of existing information, considers that the urgent amendment of a provision contained in Annexes I to IV is necessary in order to protect human or animal health, that competent authority may temporarily suspend the application of the provision concerned in its own territory. In that case, it shall immediately notify the Member States of the European Union and the European Commission about the measures, attaching a statement of the reasons therefor.

Article 10 1) The administration to food-producing animals of VMPs containing pharmacologically active substances which are not mentioned in Annexes I, II, III shall be prohibited. 2) The administration of VMPs referred to in paragraph 1 of this Article shall be permitted only in the case of clinical trials accepted by the competent authority in accordance with the legislation in force and which do not cause foodstuffs obtained from livestock participating in such trials to contain residues which constitute a hazard to human health.

Final provisions

Article 11

Annexes I to V are printed along with this Ordinance and form an integral part thereof.

Article 12 The regulation referred to in Annex II, Table 5. Substances used as food additives in foodstuffs for human consumption shall be adopted by 30 June 2008.

Article 13

The regulation referred to in Annex V, item 1.6. of this Ordinance shall be adopted by 30 June 2009.

Article 14 On the day of entry into force of this Ordinance, the Ordinance on maximum residue limits of veterinary medicines in foodstuffs (Official Gazette 29/05) shall cease to have effect.

Article 15 1) This Ordinance shall enter into force on the eighth day after the day of its publication in the Official Gazette.

2) By way of derogation from paragraph 1 of this Article, Article 9 of this Ordinance shall enter into force on the day of the entry of the Republic of Croatia into the European Union.

Class: 011-02/08-01/06 Reg. No.: 525-06-08-1 Zagreb, 24 June 2006

The Minister Božidar Pankretić, m.p.

______________ 1The Ordinance transposes the Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin

ANNEX I LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES USED IN VMPs FOR

WHICH MRLs HAVE BEEN FIXED

1. Anti-infectious agents 1.1. Chemotheurapeutics 1.1.1. Sulfonamides Pharmacologically

active substance(s) -

Croatian

Pharmacologically active

substance(s) - English

Marker residue

Animal species

MRLs

Target tissues

Other provisions

Sulfonamidi (sve tvari iz skupine sulfonamida)

All substances belonging to the sulfonamide group

Parent drug

All food-producing species

100 µg/kg

100 µg/kg

100 µg/kg

100 µg/kg

MuscleFat Liver Kidney

The combined total residues of all substances within the sulfonamide group should not exceed 100 μg/kg

Bovine,ovine, caprine

100 µg/kg

Milk

1.1.2. Diamino pyrimidine derivatives

Pharmacologically active substance(s)

- Croatian



Marker residue Animal species MRLs

Bakiloprim Baquiloprim Baquiloprim Bovine

10 µg/kg300 µg/kg

150 µg/kg30 µg/kg

Porcine 40 µg/kg50 µg/kg50 µg/kg

Trimetoprim Trimethoprim Trimethoprim All food-producing

species except equidae

50 µg/kg50 µg/kg

50 µg/kg50 µg/kg50 µg/kg

Equidae 100 µg/kg100 µg/kg100 µg/kg100 µg/kg

(1) = For porcine species and poultry this MRL relates to „skin and fat in natural proportions“

2) = For fish this MRL relates to „muscle and skin in natural proportions“ 1.2. Antibiotics 1.2.1. Penicillins Pharmacologically

active substance(s)

Pharmacologically active substance(s) -

English Marker residue Animal

species MRLs

Tartiss

Amoksicilin Amoxicyllin Amoxicyllin All food-producing species

50 µg/kg

50 µg/kg

50 µg/kg

50 µg/kg

4 µg/kg

MuFatLivKidMil

Ampicilin Ampicillin Ampicillin All food-producing species

50 µg/kg

50 µg/kg

50

MuFatLivKidMil




species MRLs

Tartiss

µg/kg50

µg/kg4

µg/kg Benzilpenicilin Benzylpenicillin Benzylpenicillin All food-

producing species

50 µg/kg

50 µg/kg

50 µg/kg

50 µg/kg

4 µg/kg

MuFatLivKidMil

Kloksacilin Cloxacillin Cloxacillin All food-producing species

300 µg/kg

300 µg/kg

300 µg/kg

300 µg/kg

30 µg/kg

MuFatLivKidMil

Dikloksacilin Dicloxacillin Dicloxacillin All food-producing species

300 µg/kg

300 µg/kg

300 µg/kg

300 µg/kg

30 µg/kg

MuFatLivKidMil

Nafcilin Nafcillin Nafcillin All ruminants

300 µg/kg

300 µg/kg

300 µg/kg

300 µg/kg

MuFatLivKidMil




species MRLs

Tartiss

30 µg/kg

Oksacilin Oxacillin Oxacillin All food-producing species

300 µg/kg

300 µg/kg

300 µg/kg

300 µg/kg

30 µg/kg

MuFatLivKidMil

Penetamat Penethamate Benzylpenicillin Bovine 50 µg/kg

50 µg/kg

50 µg/kg

50 µg/kg

4 µg/kg

MuFatLivKidMil

Porcine 50 µg/kg

50 µg/kg

50 µg/kg

50 µg/kg

MuFatLivKid

All mammalian-food producing species

50 µg/kg

50 µg/kg

50 µg/kg

50 µg/kg

4 µg/kg

MuFatLivKidMil

Fenoksimetilpenicilin Phenoxymethylpenicillin Phenoxymethylpenicillin Porcine 25 µg/kg

25

MuLivKid




species MRLs

Tartiss

µg/kg25

µg/kg Poultry 25

µg/kg25

µg/kg25

µg/kg25

µg/kg

MuSkinfat LivKid

1.2.2. Cephalosporins Pharmacologically

active substance(s)



Marker residue Animal species

MRLs

Target tissues

Othprovi

Cefacetril Cefacetrile Cefacetrile Bovine 125 µg/kg

Milk For intramause only

Cefaleksin Cefalexin Cefalexin Bovine 200 µg/kg

200 µg/kg

200 µg/kg1 000 µg/kg

100 µg/kg

MuscleFat Liver KidneyMilk

Cefalonij Cefalonium Cefalonium Bovine 20 µg/kg

Milk

Cefapirin Cephapirin Sum of cephapirin and desacetylcephapirin

Bovine 50 µg/kg

50 µg/kg

100 µg/kg

MuscleFat KidneyMilk


substance(s)




MRLs

Target tissues

Othprovi

60 µg/kg

Cefazolin Cefazolin Cefazolin Bovine, ovine and caprine

50 µg/kg

Milk

Cefoperazon Cefoperazone Cefoperazon Bovine 50 µg/kg

Milk

Cefkinom Cefquinome Cefquinome Bovine 50 µg/kg

50 µg/kg

100 µg/kg

200 µg/kg

20 µg/kg

MuscleFat Liver KidneyMilk

Porcine 50 µg/kg

50 µg/kg

100 µg/kg

200 µg/kg

MuscleSkin and fat Liver Kidney

Equidae 50 µg/kg

50 µg/kg

100 µg/kg

200 µg/kg

MuscleFat Liver Kidney

Ceftiofur Ceftiofur Sum of all residues retaining the betalactam structure expressed as desfuroylceftiofur

All mammalian food-producing species

1 000 µg/kg2 000 µg/kg2 000 µg/kg6 000 µg/kg

100

MuscleFat (1) Liver KidneyMilk

(1) = FoporcinespeciesMRL reto „skinfat in naproport


substance(s)




MRLs

Target tissues

Othprovi

µg/kg 1.2.3. Quinolones Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Otheprovisi

Danofloksacin Danofloxacin

Danofloksacin All food-producing species except bovine, ovine, caprine, porcine and poultry

100 µg/kg

50 µg/kg

200 µg/kg

200 µg/kg

Muscle (2) Fat (1) Liver Kidney

Bovine, ovine and caprine

200 µg/kg

100 µg/kg

400 µg/kg

400 µg/kg

30 µg/kg

Muscle Fat Liver Kidney Milk

Poultry 200 µg/kg

100 µg/kg

400 µg/kg

400 µg/kg

Muscle Skin and fat Liver Kidney

Not for uin animafrom wheggs areproducehuman consump

Difloksacin Difloxacin Difloxacin All food-producing species except bovine, ovine,

300 µg/kg

100 µg/kg

800 µg/kg

Muscle (2) Fat Liver Kidney


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Otheprovisi

caprine and poultry

600 µg/kg


400 µg/kg


800 µg/kg

Muscle Fat Liver Kidney

Not for uin animafrom whmilk is producehuman consump

Porcine 400 µg/kg

100 µg/kg

800 µg/kg

800 µg/kg


Poultry 300 µg/kg


600 µg/kg



Enrofloksacin Enrofloxacin Sum of enrofloxacin and ciprofloxacin

All food-producing species except bovine, ovine, caprine, porcine, rabbits and poultry

100 µg/kg

100 µg/kg

200 µg/kg

200 µg/kg

Muscle (2) Fat Liver Kidney


100 µg/kg

100 µg/kg

300 µg/kg



substance(s)



Marker residue

Animal species

MRLs

Target tissues

Otheprovisi

200 µg/kg

100 µg/kg

Porcine and rabbits

100 µg/kg

100 µg/kg

200 µg/kg

300 µg/kg

Muscle Fat (1) Liver Kidney

Poultry 100 µg/kg

100 µg/kg

200 µg/kg

300 µg/kg



Flumekin

Flumequine Flumequine All food-producing species except bovine, ovine, caprine, porcine, poultry and fin fish

200 µg/kg

250 µg/kg

500 µg/kg 1 000 µg/kg


Bovine, ovine, caprine and porcine

200 µg/kg

300 µg/kg

500 µg/kg 1 500 µg/kg

50 µg/kg

Muscle Fat (1) Liver Kidney Milk

Poultry 400 µg/kg

Muscle Skin and

Not for uin anima


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Otheprovisi

250 µg/kg

800 µg/kg 1 000 µg/kg

fat Liver Kidney

from wheggs areproducehuman consump

Fin fish 600 µg/kg

Muscle and skin in natural proportions

Marbofloksacin Marbofloxacin Marbofloxacin Bovine 150 µg/kg

50 µg/kg

150 µg/kg

150 µg/kg

75 µg/kg


Porcine 150 µg/kg

50 µg/kg

150 µg/kg

150 µg/kg


Oksolinska kiselina Oxolinic acid Oxolinic acid Porcine 100 µg/kg

50 µg/kg

150 µg/kg

150 µg/kg


Chicken 100 µg/kg

50 µg/kg

150 µg/kg


Not for uin animafrom wheggs areproducehuman


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Otheprovisi

150 µg/kg

consump

Fin fish 100 µg/kg

Muscle i koža in natural proportions

All food-producing species (3)

100 µg/kg

50 µg/kg

150 µg/kg

150 µg/kg

Muscle (1) Fat (4) Liver Kidney

Sarafloksacin Sarafloxacin Sarafloxacin Chicken 10 µg/kg

100 µg/kg

Skin and fat Liver

Salmonidae 30 µg/kg


(1) = For fin fish this MRL relates to „muscle and skin in natural proportions“. (2) = For porcine species this MRL relates to „skin and fat in natural proportions“. (3) = Not for use in animals from which milk or eggs are produced for human consumption; MRLs for fat, liver and kidney do not apply to fin fish. (4) = For porcine species and poultry thisMRL relates to „skin and fat in natural proportions“. 1.2.4. Macrolides Pharmacologically

active substance(s)


English Marker residue Animal species MRLs

Tilvalozin

Tylvalosin

Sum of tylvalosin and 3-O-acetyltylosin

Porcine 50 µg/kg50 µg/kg50 µg/kg50 µg/kg

Poultry 50 µg/kg50 µg/kg




Eritromicin Erythromycin Erythromycin A All food-producing species

200 µg/kg200 µg/kg200 µg/kg200 µg/kg40 µg/kg

150 µg/kg Spiramicin Spiramycin Sum of spiramycin

and neospiramycin Bovine 200 µg/kg

300 µg/kg300 µg/kg300 µg/kg200 µg/kg

Chicken 200 µg/kg300 µg/kg400 µg/kg

Spiramycin 1 Porcine 250 µg/kg2 000 µg/kg1 000 µg/kg

Tilmikozin Tilmicosin Tilmicosin All food-producing species except poultry

50 µg/kg50 µg/kg

1 000 µg/kg1 000 µg/kg

50 µg/kg

Poultry 75 µg/kg75 µg/kg

1 000 µg/kg250 µg/kg

Tulatromicin Tulathromycin (2R, 3S,4R,5R, 8R,10R,11R,12S,13S, 14R)-2-ethyl-3,4,10,13 -tetrahydrosy-3,5,8,10,12,14-hexamethyl-11-[[(3,4,6,-tri-deoxy-3-(di-methylamino)-β-D-xylo-hexo-

Bovine 100 µg/kg3 000 µg/kg3 000 µg/kg




pyranoxyl]ox]-1-oxa-6- aza-cyclopentadecan-15-one expressed as tulathromycin equivalents

Porcine 100 µg/kg3 000 µg/kg3 000 µg/kg

Tilozin Tylosin Tylosin A All food-producing species


200 µg/kg(1) = For porcine species this MRL relates to „skin and fat in natural proportions“. (2) = For poultry this MRL relates to „skin and fat in natural proportions“. (3) = For fin fish this MRL relates to „muscle and skin in natural proportions“. (4) = For porcine species and poultry this MRL relates to „skin and fat in natural proportions“. 1.2.5. Fluorfenicol and related compounds





Tiamfenikol Thiamphenicol Thiamphenicol All food-producing species


(1) = For fin fish „Muscle“ relates to „muscle and skin in natural proportions“ (2) = For porcine species and poultry this MRL relates to „skin and fat in natural proportions“ 1.2.6.Tetracyclines





Klortetraciklin Chlortetracycline Sum of parent drug and its 4-epimer



Doksiciklin Doxycycline Doxycycline Bovine 100 µg/kg300 µg/kg600 µg/kg

Porcine 100 µg/kg


Poultry 100 µg/kg300 µg/kg300 µg/kg600 µg/kg

Oksitetraciklin Oxytetracycline Sum of parent drug and its 4-epimer



Tetraciklin Tetracycline Sum of parent drug and its 4-epimer



1.2.7. Naphtalene-ringed ansamycin Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Rifaksimin Rifaximin Rifaximin Bovine 60 µg/kg

Milk

1.2.8. Pleuromutilines


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Tiamulin Tiamulin Sum of metabolites that may be hydrolysed to 8-a-hydroxymutilin

Porcine 100 µg/kg

500 µg/kg

Muscle Liver

Chicken 100 µg/kg

100 µg/kg 1 000 µg/kg

Muscle Skin and fat Liver

Rabbits 100 µg/kg

500 µg/kg

Muscle Liver

Turkey 100 µg/kg

100 µg/kg

300 µg/kg

Muscle Skin and fat Liver

Tiamulin 1 000 µg/kg

Eggs

Valnemulin Valnemulin Valnemulin Porcine 50 µg/kg

500 µg/kg

100 µg/kg

Muscle Liver Kidney

1.2.9. Linkozamidi Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Linkomicin Lincomycin Lincomycin All food-producing species

50 µg/kg

100 µg/kg

Fat (1) Muscle (2) Liver


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

500 µg/kg 1 500 µg/kg

150 µg/kg

50 µg/kg

KidneyMilk Eggs

Pirlimicin Pirlimycin Pirlimycin Bovine 100 µg/kg

100 µg/kg 1 000 µg/kg

400 µg/kg

100 µg/kg

Muscle Fat Liver KidneyMilk

Porcine 100 µg/kg

50 µg/kg

500 µg/kg 1 500 µg/kg


Chicken 100 µg/kg

50 µg/kg

500 µg/kg 1 500 µg/kg

50 µg/kg

Muscle Skin and fat Liver KidneyEggs

(1) = For oorcineand poultry this MRL relates to „skin and fat in natural proportions“. (2) = For fin fish this MRL relates to „muscle and skin in natural proportions“.

1.2.10. Aminoglycosides Pharmacologically

active substance(s)



species MRLs

Target tissues

Otprov

Apramicin Apramycin Apramycin Bovine 1 000 µg/kg1 000 µg/kg

10 000

µg/kg20

000 µg/kg


Not foin anifrom milk iproduhumaconsu

Dihidrostreptomicin Dihydrostreptomycin Dihydrostreptomycin All ruminants

500 µg/kg

500 µg/kg


200 µg/kg


Porcine 500 µg/kg

500 µg/kg


Muscle Koža i masno Liver Kidney

Rabbits 500 µg/kg

500 µg/kg



Streptomicin

Streptomycin Streptomycin All ruminants

500 µg/kg

500

Muscle Fat Liver




species MRLs

Target tissues

Otprov

µg/kg500

µg/kg1 000 µg/kg

200 µg/kg

KidneyMilk

Porcine 500 µg/kg

500 µg/kg



Rabbits 500 µg/kg

500 µg/kg


Muscle Masno tk Liver Kidney

Gentamicin Gentamicin Sum of gentamicin C1, gentamicin C1a, gentamicin C2 and gentamicin C2a

Bovine 50 µg/kg

50 µg/kg

200 µg/kg

750 µg/kg

100 µg/kg


Porcine 50 µg/kg

50 µg/kg

200 µg/kg

750 µg/kg


Kanamicin Kanamycin Kanamycin A All food-producing

100 µg/kg

Muscle Fat (1)

Not foin ani




species MRLs

Target tissues

Otprov

species except fin fish

100 µg/kg


150 µg/kg

Liver KidneyMilk

from eggs aproduhumaconsu

Neomicin (uključujući i framicetin)

Neomycin (including framycetin)

Neomycin B All food-producing species

500 µg/kg

500 µg/kg

500 µg/kg5 000 µg/kg1 500 µg/kg

500 µg/kg

Fat (1) Muscle (2) Liver KidneyMilk Eggs

Paromomicin Paromomycin Paromomycin All food-producing species

500 µg/kg1 500 µg/kg1 500 µg/kg

Muscle (2) Liver Kidney

Not foin anifrom milk oare produhumaconsu

Spektinomicin Spectinomycin Spectinomycin All food-producing species except sheep

500 µg/kg

300 µg/kg1 000 µg/kg5 000 µg/kg

200 µg/kg

Fat (1) Muscle (2) Liver KidneyMilk

Not foin anifrom eggs aproduhumaconsu

Ovine 300 µg/kg

500 µg/kg2 000





species MRLs

Target tissues

Otprov

µg/kg5 000 µg/kg

200 µg/kg

Streptomicin Streptomycin Streptomycin All ruminants

500 µg/kg

500 µg/kg


200 µg/kg


Porcine 500 µg/kg

500 µg/kg



Rabbits 500 µg/kg

500 µg/kg



(1) = For porcine species and poultry this MRL relates to „skin and fat in natural proportions“. (2) = For fin fish this MRL relates to „Muscle and skin in natural proportions“. 1.2.11. Other antibiotics Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Novobiocin Novobiocin Novobiocin Bovine 50 Milk


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

µg/kg 1.2.12. Polypeptides





Bacitracin Bacitracin Sum of bacitracin A, bacitracin B, and bacitracin C

Bovine 100 µg/kg

Rabbits 150 µg/kg150 µg/kg150 µg/kg150 µg/kg

1.2.13. Beta-lactamase inhibitors Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Klavulanska kiselina

Clavulanic acid Clavulanic acid

Bovine 100 µg/kg

100 µg/kg

200 µg/kg

400 µg/kg

200 µg/kg


Porcine 100 µg/kg

100 µg/kg

200 µg/kg

400 µg/kg


1.2.14. Polymyxins Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Kolistin Colistin Colistin All food-producing species

150 µg/kg

150 µg/kg

150 µg/kg

200 µg/kg

50 µg/kg

300 µg/kg

Fat (1) Muscle (2) Liver KidneyMilk Eggs

(1) = For porcine apecies and poultry this MRL relates to „skin and fat in natural proportions“. (2) = For fin fish this MRL relates to „muscle and skin in natural proportions“. 1.2.15. Orthosomycins Pharmacologically

active substance(s)




MRLs

Target tissues

Other provision

Avilamicin

Avilamycin Dichloroisoeverninic acid

Porcine 50 µg/kg

100 µg/kg

300 µg/kg

200 µg/kg

Muscle Fat (1) Liver Kidney

Kunić 50 µg/kg

100 µg/kg

300 µg/kg

200 µg/kg


Poultry 50 Muscle Not for us


substance(s)




MRLs

Target tissues

Other provision

µg/kg100

µg/kg300

µg/kg200

µg/kg

Fat (1) Liver Kidney

in animalsfrom whiceggs are produced human consumpti

(1) = For porcine apecies and poultry this MRLs relates to „skin and fat in natural proportions“ 1.2.16. Ionophores Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Monenzin Monensin Monensin A

Bovine 2 µg/kg

10 µg/kg

30 µg/kg

2 µg/kg

2 µg/kg


Lasalocid Lasalocid Lasalocid A

Poultry 20 µg/kg

100 µg/kg

100 µg/kg

50 µg/kg

150 µg/kg

Muscle Fat Liver KidneyEggs

For fat MRL relates to „skin and fat in natural proportions“

2. Antiparasitic agents 2.1. Agents acting against endoparasites 2.1.1. Salicylanilides


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Klozantel Closantel Closantel Bovine 1 000 µg/kg 3 000 µg/kg 1 000 µg/kg 3 000 µg/kg


Ovine 1 500 µg/kg 2 000 µg/kg 1 500 µg/kg 5 000 µg/kg


Rafoksanid Rafoxanide Rafoxanide Bovine 30 µg/kg

30 µg/kg

10 µg/kg

40 µg/kg


Not for use in animals from which milk is produced for human consumption

Ovine 100 µg/kg

250 µg/kg

150 µg/kg

150 µg/kg


2.1.2. Tetra-hydro-imidazoles (imidazolthiazoles) Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Levamizol Levamisole Levamisole Bovine, ovine, porcine

10 µg/kg

10

Muscle Fat Liver


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

and poultry

µg/kg 100

µg/kg 10

µg/kg

Kidney

2.1.3. Benzimidazoles and pro-benzimidazoles





MRLs

Albendazol Albendazole Sum of albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole

All ruminants 100 µg/kg100 µg/kg

1 000 µg/kg500 µg/kg100 µg/kg

Albendazol oksid Albendazole oxide Sum of albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole

Bovine and ovine

100 µg/kg100 µg/kg


Febantel Febantel Sum of extractable residues which may be oxidised to oxfendazole sulphone



Fenbendazol Fenbendazole Sum of extractable

residues which may be oxidised to oxfendazole sulphone



Flubendazol Flubendazole Sum of flubendazole

and (2-amino1H-benzimidazol-5-yl) (4fluorophenyl)

Poultry and porcine

50 µg/kg50 µg/kg

400 µg/kg300 µg/kg





MRLs

methanone Flubendazol Flubendazole Flubendazol Poultry 400 µg/kg Mebendazol Mebendazole Sum of

mebendazolemethyl (5-(1-hydroxy,1-phenyl) methyl-1H benzimidazol-2-yl) carbamateand (2 amino-1H-benzimidazol-5-yl) phenyl methanone, expressed as mebendazole equivalents

Ovine, caprine and equidae

60 µg/kg60 µg/kg

400 µg/kg60 µg/kg

Netobimin Netobimin Sum of albendazole oxide, albendazole sulphone and albendazole 2-amino sulphone, expressed as albendazole

Bovine i ovine 100 µg/kg100 µg/kg


Oksfendazol Oxfendazole Sum of extractable residues which may be oxidised to oxfendazole sulphone



Oksibendazol Oxibendazole Oxibendazole Porcine 100 µg/kg


Tiabendazol Thiabendazole Sum of thiabendazole

and 5-hydroxythiabendazole

Caprine 100 µg/kg100 µg/kg100 µg/kg100 µg/kg100 µg/kg

Triklabendazol Triclabendazole Sum of extractable residues that may be oxidised to ketotriclabendazole

All ruminants 225 µg/kg100 µg/kg250 µg/kg150 µg/kg

2.1.4. Phenol derivatives including salicylanides Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Nitroksinil Nitroxinil Nitroxinil Bovine and ovine

400 µg/kg

200 µg/kg

20 µg/kg

400 µg/kg


Oksiklozanid Oxyclozanide Oxyclozanide All ruminants

20 µg/kg

20 µg/kg

500 µg/kg

100 µg/kg

10 µg/kg


2.1.5. Benzenesulphonamides Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Klorsulon Clorsulon Clorsulon Bovine 35 µg/kg

100 µg/kg

200 µg/kg

Muscle Liver Kidney

2.1.6. Piperazine derivatives


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Piperazin Piperazine Piperazine Porcine 400 µg/kg

800 µg/kg 2 000 µg/kg 1 000 µg/kg


Chicken 2 000 µg/kg

Eggs

2.1.7. Tetrahydropyrimides Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Morantel Morantel Sum of residues which may be hydrolysed toN-methyl-1,3-propane diamine and expressed as morantel equivalents

Bovine and ovine

100 µg/kg

100 µg/kg

800 µg/kg

200 µg/kg

50 µg/kg


All ruminants

100 µg/kg

100 µg/kg

800 µg/kg

200 µg/kg

50 µg/kg


2.2. Agents acting against ectoparasites 2.2.1. Organophosphates Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Kumafos Coumafos Coumafos Bees 100 µg/kg

Med

Diazinon Diazinon Diazinon Bovine, ovine and caprine

20 µg/kg

Milk

Bovine, porcine, ovine and caprine

20 µg/kg

700 µg/kg

20 µg/kg

20 µg/kg


Foksim Phoxim Phoxim Ovine 50 µg/kg

400 µg/kg

50 µg/kg

Muscle Fat Kidney


Porcine 20 µg/kg

700 µg/kg

20 µg/kg

20 µg/kg


Chicken 25 µg/kg

550

Muscle Skin and fat


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

µg/kg 50

µg/kg 30

µg/kg 60

µg/kg

Liver KidneyEggs

2.2.2. Formamidines Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Amitraz Amitraz Sum of amitraz and all metabolites containing the 2,4-DMA moiety, expressed as amitraz

Bovine 200 µg/kg

200 µg/kg

200 µg/kg

10 µg/kg

Fat Liver KidneyMilk

Ovine 400 µg/kg

100 µg/kg

200 µg/kg

10 µg/kg


Porcine 400 µg/kg

200 µg/kg

Skin and fat Liver Kidney


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

200 µg/kg

Bees (honey)

200 µg/kg

Honey

Caprine 200 µg/kg

100 µg/kg

200 µg/kg

10 µg/kg


2.2.3. Pyrethroids Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provision

Cihalotrin Cyhalothrin Cyhalothrin (sum of isomers)

Bovine 500 µg/kg

50 µg/kg

50 µg/kg

Fat Kidney Milk

Further provisions of Ordinance on maximum residue levels of pesticides ifood and feed (Official Gazette 119/07) to


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provision

be observe1

Ciflutrin Cyfluthrin Cyfluthrin (sum of isomers)

Bovine 10 µg/kg

50 µg/kg

10 µg/kg

10 µg/kg

20 µg/kg


Deltametrin Deltamethrin Deltamethrin All ruminants

10 µg/kg

50 µg/kg

10 µg/kg

10 µg/kg

20 µg/kg


Fin fish 10 µg/kg


Fenvalerat Fenvalerate Fenvalerate (sum RR, SS, RS and isomers)

Bovine 25 µg/kg

250 µg/kg


1 Propis će se uskladiti s odredbama Uredbe Europskog Parlamenta i Vijeća (EC) 396/2005 od 23. veljače 2005. godine o maksimalnim razinama ostataka pesticida u i na hrani i hrani za životinje biljnog i životinjskog podrijetla koja nadopunjuje Direktivu Vijeća 91/414/EEC; Uredbe Komisije (EC) 178/2006 od 1. veljače 2006. godine kojom se dopunjuje Uredba Europskog Parlamenta i Vijeća (EC) 396/2005 uspostavom Aneksa I. popisa hrane i hrane za životinje na koju se maksimalne razine ostataka pesticida odnose, Uredbe Komisije (EC) 149/2008 od 29. siječnja 2008. godine kojom se dopunjuje Uredba Europskog Parlamenta i Vijeća (EC) 396/2005 uspostavom Aneksa II., III. i IV. koji određuju maksimalne razine ostataka pesticida za proizvode navedene u Aneksu I., Uredbe Komisije (EC) 260/2008 od 18. ožujka 2008. godine kojom se dopunjuje Uredba Europskog Parlamenta i Vijeća (EC) 396/2005 uspostavom Aneksa VII. popisom aktivnih tvari/kombinacija proizvoda navedenim u odredbama o iznimkama u vezi s tretiranjem fumigantima poslije žetve i Uredbe Europskog Parlamenta i Vijeća (EC) 299/2008 od 11. ožujka 2008. godine kojom se dopunjuje Uredba (EC) 396/2005 o maksimalnim razinama ostataka pesticida u i na hrani i hrani za životinje biljnog i životinjskog podrijetla u pogledu provedbe vlasti povjerene Komisiji.


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provision

25 µg/kg

25 µg/kg

40 µg/kg

Milk

Flumetrin Flumethrin Flumethrin (sum trans-Z isomers)

Bovine 10 µg/kg

150 µg/kg

20 µg/kg

10 µg/kg

30 µg/kg


Ovine 10 µg/kg

150 µg/kg

20 µg/kg

10 µg/kg


Not for usein animals from whichmilk is produced fhuman consumptio

Permetrin Permethrin Permethrin (sum of isomers)

Bovine 50 µg/kg

500 µg/kg

50 µg/kg

50 µg/kg

50 µg/kg

Muscle Fat Liver Kidney Milk*

Cipermetrin Cypermethrin Cypermethrin (sum of isomers)

Pastrvske vrste riba

50 µg/kg

Muscleand skin in natural proportions

All ruminants

20 µg/kg

200 µg/kg


* Further provisions of Ordinance


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provision

20 µg/kg

20 µg/kg

20 µg/kg

Milk* on maximum residue levels of pesticides ifood and feed (Official Gazette 119/07) to be observe

Alfacipermetrin Alphacypermethrin Cipermetrin (sum of isomers)

Bovine and ovine

20 µg/kg

200 µg/kg

20 µg/kg

20 µg/kg

20 µg/kg

Muscle Fat Liver Kidney Milk*

* Further provisions of Ordinance on maximum residue levels of pesticides ifood and feed (Official Gazette 119/07) to be observe

* The regulation will be aligned with the provisions of the Regulation (EC) 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC; Commission Regulation (EC) 178/2006 of 1 February 2006 amending Regulation (EC) 396/2005 of the European Parliament and of the Council to establish Annex I listing the food and feed products to which maximum levels for pesticide residues apply, Commission Regulation (EC) 149/2008 of 29 January 2008 amending Regulation (EC) No. 396/2005 of the European Parliament and of the Council by establishing Annexes II, III and IV setting maximum residue levels for products covered by Annex 1 thereto, Commission Regulation (EC) 260/2008 of 18 March 2008 amending Regulation (EC) 396/2005 of the European Parliament and of the Council by establishing Annex VII listing active substances/product combinations covered by a derogation as regards post harvest treatments with a fumigant and Regulation (EC) 299/2008 of the European Parliament and of the Council of 11 March 2008 amending Regulation (EC) 396/2005 on maximum resiude levels of pesticides in or on food and feed of plant and animal origin, as regards the implementing powers conferred on the Commission. 2.2.4. Acyl urea derivatives


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Otheprovisi

Diflubenzuron Diflubenzuron Diflubenzuron Salmonidae 1 000 µg/kg


Fluazuron Fluazuron Fluazuron Bovine 200 µg/kg7 000 µg/kg

500 µg/kg

500 µg/kg


Not for uin animafrom whmilk is producedhuman consump

Teflubenzuron Teflubenzuron Teflubenzuron Salmonidae 500 µg/kg


2.2.5. Pyrimidines derivatives Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Diciklanil Dicyclanil Sum of dicyclanil and 2, 4, 6-triamino-pyrimidine-5-carbonitrile

Ovine 200 µg/kg

150 µg/kg

400 µg/kg

400 µg/kg



2.2.6. Triazine derivatives Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Ciromazin Cyromazine Cyromazine Ovine 300 µg/kg

Muscle Fat

Not for use in animals


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

300 µg/kg

300 µg/kg

300 µg/kg

Liver Kidney

from which milk is produced for human consumption

2.3. Agents acting against endo- and ectoparasites 2.3.1. Avermectins Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Otherprovisio

Abamektin Abamectin Avermektin B1a

Bovine 10 µg/kg

20 µg/kg

Fat Liver

Ovine 20 µg/kg

50 µg/kg

25 µg/kg

20 µg/kg


Not for usin animalfrom whimilk is producedhuman consumpt

Doramektin Doramectin Doramectin All mammalian food producing species

40 µg/kg

150 µg/kg

100 µg/kg

60 µg/kg



Emamektin Emamectin Emamectin B1a

Fin fish 100 µg/kg


Eprinomektin Eprinomectin Eprinomectin B1a

Bovine 50 µg/kg

250

Muscle Fat Liver


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Otherprovisio

µg/kg 1 500 µg/kg

300 µg/kg

20 µg/kg

Kidney Milk

Ivermektin Ivermectin 22, 23-Dihydro-avermectin B1a

Bovine 40 µg/kg

100 µg/kg

Fat Liver

Porcine, ovine, equidae

20 µg/kg

15 µg/kg

Fat Liver

Deer, including reindeer

20 µg/kg

100 µg/kg

50 µg/kg

20 µg/kg


All mammalian food producing species

100 µg/kg

100 µg/kg

30 µg/kg

Muscle Liver Kidney


Moksidektin Moxidectin Moxidectin Bovine and ovine

50 µg/kg

500 µg/kg

100 µg/kg

50 µg/kg


Bovine 40 µg/kg

Milk

Equidae 50 µg/kg

Muscle Fat


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Otherprovisio

500 µg/kg

100 µg/kg

50 µg/kg

Liver Kidney

Ovine 40 µg/kg

Milk

2.4. Agents acting against protozoa 2.4.1. Triazinetrione derivative Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Toltrazuril Toltrazuril Toltrazuril sulfon

Chicken 100 µg/kg

200 µg/kg

600 µg/kg

400 µg/kg


Not for use in animals from which eggs are produced for human consumption

Purani 100 µg/kg

200 µg/kg

600 µg/kg

400 µg/kg


Porcine 100 µg/kg

150 µg/kg

500 µg/kg

250 µg/kg


All mammalian food

100 µg/kg

150

Muscle Fat(1) Liver

Not for use in animals from which


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

producing species

µg/kg 500

µg/kg 250

µg/kg

Kidney milk is produced for human consumption

Poultry 100 µg/kg

200 µg/kg

600 µg/kg

400 µg/kg


Not for use in animals from which eggs are produced for human consumption

(1) = For porcine species this MRL relates to „skin and fat in natural proportions“

2.4.2. Quinazolone derivatives Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Halofuginon Halofuginone Halofuginone Bovine 10 µg/kg

25 µg/kg

30 µg/kg

30 µg/kg



2.4.3. Carbanilides Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Imidokarb Imidocarb Imidocarb Bovine 300 µg/kg

50 µg/kg 2 000 µg/kg 1 500



substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

µg/kg 50

µg/kg Ovine 300

µg/kg 50

µg/kg 2 000 µg/kg 1 500 µg/kg



3. Agents acting on the nervous system 3.1. Agents acting on the central nervous system 3.1.1. Butyrophenone tranquillisers Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Azaperon Azaperone Sum of azaperone and azaperol

Porcine 100 µg/kg

100 µg/kg

100 µg/kg

100 µg/kg


3.2. Agents acting on the autonomic nervous system 3.2.1. Anti-adrenergics Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Karazolol Carazolol Carazolol Porcine 5 µg/kg

5 µg/kg

25 µg/kg

25

Muscle Koža i masno tki. Liver Kidney


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

µg/kg Bovine 5

µg/kg 5

µg/kg 15

µg/kg 15

µg/kg 1

µg/kg


3.2.2. ß2- sympathomimetic agents Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Klenbuterolklorid Clenbuterol hydrochloride

Clenbuterol Bovine 0,1 µg/kg

0,5 µg/kg

0,5 µg/kg 0,05

µg/kg

Muscle Liver KidneyMilk

Equidae 0,1 µg/kg

0,5 µg/kg

0,5 µg/kg

Muscle Liver Kidney

4. Anti-inflammatory agents 4.1. Nonsteroidal anti-inflammatory agents 4.1.1. Arylpropionic acid derivative Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Karprofen Carprofen Carprofen Bovine 500 µg/kg 1 000 µg/kg 1 000 µg/kg 1 000 µg/kg



Equidae 500 µg/kg 1 000 µg/kg 1 000 µg/kg 1 000 µg/kg


Vedaprofen Vedaprofen Vedaprofen Equidae 50 µg/kg

20 µg/kg

100 µg/kg 1 000 µg/kg


Karprofen Carprofen Sum of carprofen and carprofen glucuronide conjugate

Bovine i Equidae

500 µg/kg 1 000 µg/kg 1 000 µg/kg 1 000 µg/kg


4.1.2. Fenamate group derivatives Pharmacologically

active substance(s)




MRLs

Target tissues

Other provisions

Fluniksin Flunixin Flunixin Bovine 20 µg/kg

Muscle Fat


substance(s)




MRLs

Target tissues

Other provisions

30 µg/kg

300 µg/kg

100 µg/kg

Liver Kidney

5- Hydroxyflunixin

Bovine 40 µg/kg

Milk

Flunixin Porcine 50 µg/kg

10 µg/kg

200 µg/kg

30 µg/kg


Equidae 10 µg/kg

20 µg/kg

100 µg/kg

200 µg/kg


Tolfenamatna kiselina

Tolfenamic acid Tolfenamic acid Bovine 50 µg/kg

400 µg/kg

100 µg/kg

50 µg/kg


Porcine 50 µg/kg

400 µg/kg

100 µg/kg

Muscle Liver Kidney

4.1.3. Enolic acid derivates


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

4.1.4. Oxican derivatives Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Meloksikam Meloxicam Meloxicam Porcine, equidae and rabbits

20 µg/kg

65 µg/kg

65 µg/kg

Muscle Liver Kidney

Bovine and caprine

20 µg/kg

65 µg/kg

65 µg/kg

15 µg/kg


4.1.5. Pyrazolone derivatives Pharmacologically

active substance(s)




MRLs

Target tissues

Otherprovisio

Metamizol Metamizole 4- Methylaminoantipyrin

Bovine 100 µg/kg

100 µg/kg

100 µg/kg

100 µg/kg

50 µg/kg


Porcine 100 µg/kg

100

Muscle Skin and fat


substance(s)




MRLs

Target tissues

Otherprovisio

µg/kg100

µg/kg 100

µg/kg

Liver Kidney

Equidae 100 µg/kg

100 µg/kg

100 µg/kg

100 µg/kg


4.1.6. Phenyl acetic acid derivatives Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Diklofenak Diclofenac Diclofenak Bovine 5 µg/kg

1 µg/kg

5 µg/kg

10 µg/kg



Porcine 5 µg/kg

1 µg/kg

5 µg/kg

10 µg/kg


4.1.7. Sulphonated fenyl lactones


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Firokoksib Firocoxib Firocoxib Equidae 10 µg/kg

15 µg/kg

60 µg/kg

10 µg/kg


5. Corticoides 5.1. Glucocorticoides Pharmacologically

active substance(s)


- English Marker residue Animal

species MRLs

Target tissues

Other provision

Betametazon Betamethasone Betamethasone Bovine 0,75 µg/kg

2 µg/kg

0,75 µg/kg

0,3 µg/kg


Porcine 0,75 µg/kg

2 µg/kg

0,75 µg/kg

Muscle Liver Kidney

Deksametazon Dexamethasone Dexamethasone Bovine 0,3 µg/kg

Milk

Bovine, porcine and equidae

0,75 µg/kg

2 µg/kg

0,75 µg/kg

Muscle Liver Kidney

Caprine 0,75 µg/kg

2 µg/kg

0,75



substance(s)


- English Marker residue Animal

species MRLs

Target tissues

Other provision

µg/kg0,3

µg/kg Metilprednizolon Methylprednisolone Methylprednisolone Bovine 10

µg/kg10

µg/kg10

µg/kg 10

µg/kg


Not for usein animals from whichmilk is produced fhuman consumptio

Prednizolon Prednisolone Prednisolone Bovine 4 µg/kg

4 µg/kg

10 µg/kg

10 µg/kg

6 µg/kg


6. Agents acting on the reproductive system

6.1. Progestogens Pharmacologically

active substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

Klormadinon Chlormadinone Chlormadinone Bovine 4 µg/kg

2 µg/kg

2,5 µg/kg

Fat Liver Milk

For zootechnical use only

Flugeston acetat Flugestone acetate Flugestone acetate

Ovine 1 µg/kg

Milk For intravaginal use for zootechnical purposes only

Caprine 1 Milk For


substance(s)



Marker residue

Animal species

MRLs

Target tissues

Other provisions

µg/kg intravaginal use for zootechnical purposes only

Ovine i caprine

0,5 µg/kg

0,5 µg/kg

0,5 µg/kg

0,5 µg/kg


For therapeutic and zootechnical purposes only

Altrenogest Altrenogest (1) Altrenogest Porcine 1 µg/kg

0,4 µg/kg

Skin and fat Liver

Equidae 1 µg/kg

0,9 µg/kg

Fat Liver

Norgestomet Norgestomet Norgestomet Bovine 0,2 µg/kg

0,2 µg/kg

0,2 µg/kg

0,2 µg/kg

0,12 µg/kg


For therapeutic and zootechnical purposes only

(1) = For zootechnical purposes only in accordance with Order prohibiting the use in stockfarming of certain beta-agonists and substances having a hormonal or thyrostatic action (Official Gazette21/03) transposing the provisions of Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists.

ANNEX II

LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES USED IN VMPs NOT

SUBJECT TO MAXIMUM RESIDUE LIMITS

1. Inorganic chemicals

Pharmacologically active substance(s) - Croatian

Pharmacologically active substance(s) - English

Animal species Other provisions

1. Aluminijev distearat Aluminium distearate All food-producing species 2. Aluminijev hydroksid

acetatat Aluminium hydroxide acetate


3. Aluminijev fosfat Aluminium phosphate All food-producing species 4. Aluminijev salicilat,

bazični Aluminium salicylate, basic

Bovine For oral use only. Not for use in animals from which milk is produced for human consumption

5. Aluminijev tristearat Aluminium tristearate All food-producing species 6. Aluminijev klorid Aluminium chloride All food-producing species 7. Barijev selenat Barium selenate Bovine, ovine 8. Bizmutov subkarbonat Bismuth subcarbonate All food-producing species For oral use only 9. Bizmutov subgalat Bismuth subgallate All food-producing species For oral use only 10. Bizmutov subnitrat Bismuth subnitrate All food-producing species For oral use only 11. Bizmutov subsalicilat Bismuth subsalicylate All food-producing species For oral use only 12. Borna kiselina i borati Boric acid and borates All food-producing species 13. Bromid, kalijeva sol Bromide, potassium

salt All food-producing species For topical use only

14. Bromid, natrijeva sol Bromide, sodium salt All mammalian food-producing species

15. Kalcijev Calcium acetate All food-producing species 16. Kalcijev benzoat Calcium benzoate All food-producing species 17. Kalcijev karbonat Calcium carbonate All food-producing species 18. Kalcijev klorid Calcium chloride All food-producing species 19. Kalcijev glukonat Calcium gluconate All food-producing species 20. Kalcijev hidroksid Calcium hydroxide All food-producing species 21. Kalcijev hipofosfit Calcium

hypophosphite All food-producing species

22. Kalcijev malat Calcium malate All food-producing species 23. Kalcijev oksid Calcium oxide All food-producing species 24. Kalcijev fosfat Calcium phosphate All food-producing species 25. Kalcijev polifosfat Calcium

polyphosphates All food-producing species

26. Kalcijev propionat Calcium propionate All food-producing species 27. Kalcijev silikat Calcium silicate All food-producing species 28. Kalcijev stearat Calcium stearate All food-producing species 29. Kalcijev sulfat Calcium sulphate All food-producing species 30. Kalcijev glukoheptonat Calcium

glucoheptonate All food-producing species

31. Kalcijev glukonoglukoheptonat

Calcium glucono glucoheptonate


32. Kalcijev glukonolaktat Calcium All food-producing species




gluconolactate 33. Kalcijev glutamate Calcium glutamate All food-producing species 34. Kalcijev glicerofosfat Calcium

glycerophosphate All food-producing species

35. Kobaltov karbonat Cobalt carbonate All food-producing species 36. Kobaltov diklorid Cobalt dichloride All food-producing species 37. Kobaltov glukonat Cobalt gluconate All food-producing species 38. Kobaltov oksid Cobalt oxide All food-producing species 39. Kobaltov sulfat Cobalt sulphate All food-producing species 40. Kobaltov trioksid Cobalt trioxide All food-producing species 41. Bakrov klorid Copper chloride All food-producing species 42. Bakrov gluconat Copper gluconate All food-producing species 43. Bakrov heptanoat Copper heptanoate All food-producing species 44. Bakrov metionat Copper methionate All food-producing species 45. Bakrov oksid Copper oxide All food-producing species 46. Bakrov sulfat Copper sulphate All food-producing species 47. Dicopper oxide All food-producing species 48. Kloridna kiselina Hydrochloric acid All food-producing species For use as excipient 49. Vodikov peroksid Hydrogen peroxide All food-producing species 50. Jod i anorganski spojevi

joda uključujući: -Natrije i kalijev jodid -Natrijev i kalijev jodat -Jodofori uključujući polivinlpirolidone

Iodine and iodine inorganic compounds including: - Sodium and potassium-iodide - Sodium and potassium-iodate - Iodophors including polyvinylpyrrolidone-iodine


51. Željezov diklorid Iron dichloride All food-producing species 52. Željezov sulfat Iron sulphate All food-producing species 53. Magnezij

Magnezijev sulfat Magnezijev hidroksid Magnezijev stearat Magnezijev glutamat Magnezijev orotat Magnezijev aluminij silikat Magnezijev oksid Magnezijev karbonat Magnezijev fosfat Magnezijev glicerofosfat

Magnesium Magnesium sulphate Magnesium hydroxide Magnesium stearate Magnesium glutamate Magnesium orotate Magnesium aluminium silicate Magnesium oxide Magnesium carbonate Magnesium phosphate Magnesium





Magnezijev aspartat Magnezijev citrat Magnezijev acetat Magnezijev trisilikat

glycerophosphate Magnesium aspartate Magnesium citrate Magnesium acetate Magnesium trisilicate

54. Niklov glukonat Nickel gluconate All food-producing species 55. Niklov sulfat Nickel sulphate All food-producing species 56. Kalijev DL aspartat Potassium DL-

aspartate All food-producing species

57. Kalijev glukuronat Potassium glucuronate All food-producing species 58. Kalijev glicerofosfat Potassium

glycerophosphate All food-producing species

59. Kalijev nitrat Potassium nitrate All food-producing species 60. Kalijev selenat Potassium selenate All food-producing species 61. Natrijev klorit Sodium chlorite Bovine For topical use only 62. Natrijev

dikloroizocianurat Sodium dichloroisocyanurate

Bovine, ovine, caprine For topical use only

63. Natrijev glicerofosfat Sodium glycerophosphate


64. Natrijev hipofosfit Sodium hypophosphite All food-producing species 65. Natrijev nitrit Sodium nitrite Bovine For topical use only 66. Natrijev propionat Sodium propionate All food-producing species 67. Natrijev selenat Sodium selenate All food-producing species 68. Natrijev selenit Sodium selenite All food-producing species 69. Sumpor Sulphur All food-producing species 70. Cinkov acetat Zinc acetate All food-producing species 71. Cinkov klorid Zinc chloride All food-producing species 72. Cinkov glukonat Zinc gluconate All food-producing species 73. Cinkov oleat Zinc oleate All food-producing species 74. Cinkov stearat Zinc stearate All food-producing species

2. Organic compounds

cologically active ce(s) - Croatian



radiol 17β-Oestradiol All food-producing species For therapeutic and zootechnical uses only oetanol 2-Aminoethanol All food-producing species oetil enfosfat

2-Aminoethyl dihydrogenphosphate


don 2-Pyrrolidone All food-producing species At parenteral doses up to 40 mg/kg bw ksikinolin 8-Hydroxyquinoline All mammalian food-

producing species For topical use in newborn animals only




stein Acetyl cysteine All food-producing species idol Alfacalcidol Bovine For parturient cows only

stol Alfaprostol Rabbits, bovine, porcine, equidae

in Bacitracin Bovine

For intramammary use in lactating cows and for aexcept milk

onijev klorid Benzalkonium chloride All food-producing species For use as an excipient at concentrations up to 0.0ain Benzocaine All food-producing species For use as local anaesthetic only

alkohol Benzylalcohol All food-producing species For use as excipient Betaine All food-producing species

ol Bronopol Salmonidae For use only on farmed fertilised eggs am Brotizolam Bovine For therapeutic uses only n Buserelin All food-producing species

nolov tartarat Butorphanol tartrate Equidae

For intravenous administration only

hidroksibenzoat Butyl 4-hydroxybenzoate


polaminiumov Butylscopolaminium bromide


Caffeine All food-producing species cin Carbetocin All mammalian food-

producing species

n Cefazolin Bovine, ovine, caprine For intramammary use, except if the udder may bfood for human consumption

stearilni alkohol Cetostearyl alcohol All food-producing species d Cetrimide All food-producing species sidin Chlorhexidine All food-producing species For topical use only ezol Chlorocresol All food-producing species

Clazuril Golubovi tenol Cloprostenol Bovine, porcine i equidae v alkih dimetil Coco alkyl dimethyl

betaines All food-producing species For use as excipient

ropin Corticotropin All food-producing species Luteinizrajući oslobađanja

D-Phe 6 -luteinising-hormone releasing hormone


ksin Dembrexine Equidae in hidroklorid Denaverine

hydrochloride Bovine

din Detomidine Bovine, equidae For therapeutic uses only ril Diclazuril All ruminants, porcine For oral use only lat Diethyl phtalate All food-producing species




lni eter glikola

Diethylene glycol monoethyl ether

Bovine, porcine

anov trioksid Dimanganese trioxide All food-producing species For oral use only ftalat Dimethyl phtalate All food-producing species st Dinoprost All mammalian food-

producing species

sttrometamin Dinoprost tromethamine All mammalian food-producing species

in Diprophylline All food-producing species ilin Etamiphylline

camsylate All food-producing species

Ethanol All food-producing species For use as excipient at Ethyl lactate All food-producing species ton Etiproston

tromethamine Bovine, porcine

acetat Fertirelin acetate Bovine n Flumethrin Bees (honey) kiselina Folic acid All food-producing species l formal Glycerol formal All food-producing species ropni hormon

anja Gonadotrophin releasing hormone


nol Heptaminol All food-producing species din Hesperidin Equidae din metil Hesperidin methyl

chalcone Equidae

din Hexetidine Equidae For topical use only korionski ropin

Human chorion gonadotrophin


menopauzalni gonadotropin

Human menopausal urinary gonadotrophin

Bovine

rtizon Hydrocortisone All food-producing species For topical use only i jod spojevi -

m Iodine organic compounds — Iodoform


n Isobutane All food-producing species n Isoflurane Equidae For use as anaesthetic only rin Isoxsuprine Bovine, equidae For therapeutic use only in accordance with the O

prohibiting the use in stockfarming of certain beta




and substances having a hormonal or thyrostatic a21/03)2

Ketamine All food-producing species rin tartrat Ketanserin tartrate equidae fen Ketoprofen Bovine, porcine, equidae na kiselina I mono i di bazične ija, kalija i kalcija

L-tartaric acid and its mono- and di-basic salt of sodium, potassium and calcium

All food-producing species For use as excipient

a kiselina Lactic acid All food-producing species n Lecirelin Bovine, equidae, rabbits

Lobeline All food-producing species ol Luprostiol All mammalian species a kiselina Malic acid All food-producing species For use as excipient ov karbonat Manganese carbonate All food-producing species For oral use only ov klorid Manganese chloride All food-producing species For oral use only ov glukonat Manganese gluconate All food-producing species For oral use only ov glicerofosfat Manganese

glycerophosphate All food-producing species For oral use only

ov oksid Manganese oxide All food-producing species For oral use only ov pidolat Manganese pidolate All food-producing species For oral use only ov ribonukleat Manganese ribonucleate All food-producing species For oral use only ov sulfat Manganese sulphate All food-producing species For oral use only am Mecillinam Bovine For use as excipient siprogesteronacetat Medroxyprogesterone

acetate Ovine For intravaginal use for zootechnical purposes on

in Melatonin Ovine, caprine on Menadione All food-producing species on Menbutone Bovine, ovine, caprine,

porcine, equidae

Menthol All food-producing species kotinat Methyl nicotinate Bovine, equidae For topical use only ni ugljikovodici, visoko viskozni

ući mikrokristalini približno C10-

fatski, podjela na i

Mineral hydrocarbons, low to high viscosity including microcris-talline waxes, approximately C10-C60; aliphatic,

All food-producing species Excludes aromatic and unsaturated compounds

2The Order transposes the provisions of Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC




ne spojevi branched aliphatic and alicyclic compounds N-butane All food-producing species

ol N-butanol All food-producing species For use as excipient in Natamycin Bovine, equidae For topical use only

min Neostigmine All food-producing species ksil Nicoboxil Equidae For topical use only mid Nonivamide Equidae For topical use only leat Oleyloleate All food-producing species For topical use only n Oxytocin All mammalian food-

producing species

tin Pancreatin All mammalian food-producing species

For topical use only

Papain All food-producing species in Papaverine Bovine Newborn calves only tna kiselina Peracetic acid All food-producing species

Phenol All food-producing species ciol Phloroglucinol All food-producing species adion Phytomenadione All food-producing species ulen Policresulen All food-producing species For topical use only n glikol 15 stearat

Polyethylene glycol 15 hydroxystearate


n glikol 7 gliceril Polyethylene glycol 7 glyceryl cocoate

All food-producing species For topical use only

n glikol stearat sa ietilenskih

Polyethylene glycol stearates with 8-40 oxyethylene units


at minglikan

Polysulphated glycosaminoglycan

Equidae

antel Praziquantel Ovine, equidae For use in non-lactating sheep only drebnih kobila Pregnant mare serum

gonadotrophin All food-producing species

id (krotetamid i amid)

Prethcamide (crotethamide and cropropamide)


Procaine All food-producing species Propane All food-producing species

glikol Propylene glycol All food-producing species n Quatresin All food-producing species For use as preservative only at concentrations of uostenol R-Cloprostenol Bovine, porcine, equidae

min Rifaximin All mammalian food-producing species, bovine

For topical use only For intramammary use, except if the udder may b




food for human consumption in Romifidine Equidae For therapeutic uses only 2-metil 2 fenoksi at

Sodium 2-methyl-2-phenoxy-propanoate

Bovine, porcine, caprine, equidae

benzil 4 benzoat

Sodium benzyl 4-hydroxybenzoate


butil 4 benzoat

Sodium butyl 4-hydroxybenzoate


cetostearilsulfat Sodium cetostearyl sulphate


alm Somatosalm Salmon m Tanninum All food-producing species alinat Tau fluvalinate idrat Terpin hydrate Bovine, porcine, ovine,

caprine

n Tetracaine All food-producing species For use as anaesthetic only min Theobromine All food-producing species

Theophylline All food-producing species al Thiomersal All food-producing species For use only as preservatives in multidose vaccine

concentration not exceeding 0.02 % Thymol All food-producing species

nat Timerfonate All food-producing species For use only as preservatives in multidose vaccineconcentration not exceeding 0.02 %

idroglucinol Trimethylphloroglucinol All food-producing species D Vitamin D All food-producing species

ski alkoholi Wool alcohols All food-producing species For topical use only 2-pirolidon 1 -Methyl-2-pyrrolidone Equidae il Cefacetrile Bovine For intramammary use only and for all tissues excazol Enilconazole Bovine, equidae For topical use only at Etamsylate All food-producing species n Strychnine bovine For oral use only, at dose to 0.1 mg/kg bw zol Parconazole Guinea fowl

Biotin All food-producing species ksin Bromhexine Bovine

Not for use in animals from which milk is produced for human consumption Porcine Poultry Not for use in animals from which eggs are produced for human consumption




aminhidroklorid Mercaptamine hydrochloride


antel Praziquantel Ovine embonat Pyrantel embonate Equidae B1 Vitamin B1 All food-producing species B12 Vitamin B12 All food-producing species B2 Vitamin B2 All food-producing species B3 Vitamin B3 All food-producing species B5 Vitamin B5 All food-producing species B6 Vitamin B6 All food-producing species E Vitamin E All food-producing species

Tiaprost Bovine, ovine, porcine, equidae

cin Apramycin Porcine, rabbits Ovine Not for use in animals from which milk is produced for human consumption Chicken Not for use in animals from which eggs are produced for human consumption

For oral use only

hifos Azamethiphos Salmonidae am Doxapram All mammalian food

producing species

l butoksid Piperonyl butoxide Bovine, ovine, caprine, equidae


akol Sulfogaiacol All food-producing species tin hidroklorid Vetrabutine

hydrochloride Porcine

amid hidroklorid Fenpipramide hydrochloride

Equidae For intravenous use only

ortiazid Hydrochlorothiazide Bovine tadon Levomethadone Equidae For intravenous use only mesilat Tricaine mesilate Fin fish For water borne use only

metiazid Trichlormethiazide All mammalian food producing species

Not for use in animals from which milk is produchuman consumption

in Vincamine Bovine For use in newborn animals only Atropine All food-producing species

azon Cefoperazone Bovine For intramammary use in lactating cows only and




tissues except milk etanol glukuronat 2-aminoethanol

glucuronate All food-producing species

lukuronat Betaine glucuronate osulfonati, ve i natrijeve soli

Bituminosulfonates, ammonium and sodium salts

All mammalian food producing species


amin Chlorphenamine All mammalian food producing species

For oral use only

ka kiseline i natrijeve soli

Humic acids and their sodium salts


mol Paracetamol Porcine For oral use only ramid natrij Tosylchloramide

sodium – m88, 125 Fin fish, Bovine Equidae

For water-borne use only For topical use only For topical use only

2-pirolidon 1 -methyl-2-pyrrolidone All food-producing species rin maleat Ergometrine maleate All mammalian food-

producing species For use in parturient animals only

je Jecoris oleum All food-producing species For topical use only kain Mepivacaine Equidae For intra-articular and epidural use as local anaestocin Novobiocin Bovine For intrammary use only and for all tissues excepn dihidroklorid Piperazine

dihydrochloride Chicken For all tissues except eggs

l ricinus ulje sa ksietilenskih

Polyoxyl castor oil with 30 to 40 oxyethylene units


l hidrogenizirano vo ulje sa 40-60 nskih jedinica

Polyoxyl hydrogenated castor oil with 40 to 60 oxyethylene units


hidroklorid Xylazine hydrochloride Bovine, equidae Not for use in animals from which milk is produchuman consumption

fan Butafosfan Bovine For intravenous use only j Cefalonium Bovine For intramammary use and eye treatment only, an

tissues except milk mid Furosemide Bovine, equidae For intravenous administration only n Lidocaine Equidae For local-regional anaesthesia only dov L-tirozin 3,5-Diiodo-L-thyrosine All mammalian food-

producing species

ksin Levothyroxine All mammalian food-producing species

aluminijev Aluminium salicylate, All food producing species For topical use only




basic except fish v subnitrat Bismuth subnitrate Bovine For intramammary use only aspartat Calcium aspartate All food-producing species

licilat Methyl salicylate All food-producing species, except fish


na kiselina Salicylic acid All food-producing species, except fish


salicilat Sodium salicylate Bovine, porcine For oral use. Not for use in animals from which mproduced for human consumption

aspartat Zinc aspartate All food-producing species os Toldimfos All food-producing species nat Decoquinate Bovine, ovine For oral use. Not for use in animals from which m

produced for human consumption boroformijat Sodium boroformiate All food-producing species

Thiamylal All mammalian food producing species For intravenous administration only

al natrij Thiopental sodium All food-producing species For intravenous administration only licilna kiselina Acetylsalicylic acid All food-producing species,

except fish Not for use in animals from which milk or eggs arfor human consumption

licilna kiselina DL Acetylsalicylic acid DL-lysine

All food-producing species, except fish

Not for use in animals from which milk or eggs arfor human consumption

at kalcij Carbasalate calcium All food-producing species, except fish


acetilsalicilat Sodium acetylsalicylate All food-producing species, except fish


a alkil benzen a kiselina s lancem dužine od 13 koja sadrži

d 2,5% lanca dužih

Linear alkyl benzene sulphonic acids with alkyl chain lengths ranging from C9 to C13, containing less than 2,5 % of chains longer than C13

Bovine, ovine For topical use only

soli Amprolium Poultry For oral use only nska kiselina, ve

Tiludronic acid, disodium salt

Equidae For intravenous use only

trioleat Sorbitan trioleate All food-producing species A Vitamin A All food-producing species

ev laurilsulfat Ammonium lauryl sulphate


ol Bronopol Fin fish pantotenat Calcium pantothenate All food-producing species

n Allantoin All food-producing species For topical use only




ain Benzocaine Salmonidae ntenol Dexpanthenol All food-producing species nafarelin Azagly-nafarelin Salmonidae Not for use in fish from which eggs are produced

consumption in acetat Deslorelin acetate Equidae ietilsalicilat Hydroxyethylsalicylate All food-producing species,

except fish For topical use only

hidroklorid Xylazine hydrochloride Bovine, equidae zol Omeprazole Equidae For oral use only

metiazid Trichlormethiazide All mammalian food producing species

ron Progesterone (*) Bovine, ovine, caprine, Equidae (female)

Only for intravaginal therapeutic or zootechnical accordance with the Order prohibiting the use in stockfarming of certain beta-agonists and substana hormonal or thyrostatic action (OG 21/03)3

etazondipropionat Beclomethasone dipropionate

Equidae For inhalation only

tenol Cloprostenol Caprine ostenol R-cloprostenol Caprine

seskvioleat Sorbitan sesquioleate All food-producing species glikol monoetil Diethylene glycol

monoethyl ether All ruminants and porcine

n Peforelin Porcine

3. Substances generally recognised as safe

Pharmacologically active ubstance(s) - Croatian



Ekstrakt pelina Absinthium extract All food-producing species Acetilmetionin Acetylmethionine All food-producing species Aluminijev hidroksid Aluminium hydroxide All food-producing species Aluminijev monostearat Aluminium monostearate All food-producing species Amonijev sulfat Ammonium sulfate All food-producing species Benzoil benzoat Benzoyl benzoate All food-producing species Benzil p-hidroksibenzoat Benzyl p-hydroxybenzoate All food-producing species Kalcijev boroglukonat Calcium borogluconate All food-producing species Kalcijev citrat Calcium citrate All food-producing species

3 The Order transposes the provisions of Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC




Kamfor Camphor All food-producing species For topical use only Ekstrakt kardamona Cardamon extract All food-producing species Dietil sebakat Diethyl sebacate All food-producing species Dimetikon Dimethicone All food-producing species Dimetil acetamid Dimethyl acetamide All food-producing species Dimetil sulfoksid Dimethyl sulphoxide All food-producing species Epinefrin Epinephrine All food-producing species Etiloleat Ethyl oleate All food-producing species Etilendiamintetraacetatna iselina i njezine soli

Ethylenediaminetetraacetic acid and salts


Eukaliptol Eucalyptol All food-producing species olikulostimulirajući ormon (prirodni FSH od vih vrsta i njihovih intetskih analoga)

Follicle stimulating hormone (natural FSH from all species and their synthetic analogues)


ormaldehid Formaldehyde All food-producing species Mravlja kiselina Formic acid All food-producing species Glutaldehid Glutaraldehyde All food-producing species Gvajakol Guaiacol All food-producing species Heparin i njegove soli Heparin and its salts All food-producing species Ljudski korionski onadotropin (prirodni

HCG i njegovi sintetski nalozi)

Human chorionic gonadotropin (natural HCG and its synthetic analogues)


Željezov amonij citrat Iron ammonium citrate All food-producing species Željezov dekstran Iron dextran All food-producing species Željezov glukoheptonat Iron glucoheptonate All food-producing species zopropanol Isopropanol All food-producing species

Lanolin Lanolin All food-producing species Luteinizirajući hormon prirodni LH od svih vrsta njihovi sintetski analozi

Luteinising hormone (natural LH from all species and their synthetic analogues)


Magnezijev klorid Magnesium chloride All food-producing species Magnezijev glukonat Magnesium gluconate All food-producing species Magnezijev hipofosfit Magnesium hypophosphite All food-producing species Manitol Mannitol All food-producing species Metilbenzoat Methylbenzoate All food-producing species Monotioglicerol Monothioglycerol All food-producing species Montanid Montanide All food-producing species Migliol Myglyol All food-producing species Orgotein Orgotein All food-producing species

oloksalen Poloxalene All food-producing species




oloksamer Poloxamer All food-producing species olietilenski glikoli molekularne težine od 00-10000)

Polyethylene glycols (molecular weight ranging from 200 to 10 000)


olisorbat 80 Polysorbate 80 All food-producing species erotonin Serotonin All food-producing species

Natrijev klorid Sodium chloride All food-producing species Natrijev kromoglikat Sodium cromoglycate All food-producing species Natrijev ioktilsulfosukcinat

Sodium dioctylsulphosuccinate


Natrijev ormaldehidsulfoksilat

Sodium formaldehydesulphoxylate


Natrijev lauril sulfat Sodium lauryl sulphate All food-producing species Natrijev pirosulfit Sodium pyrosulphite All food-producing species Natrijev stearat Sodium stearate All food-producing species Natrijev tiosulfat Sodium thiosulphate All food-producing species Tragant Tragacanth All food-producing species Urea Urea All food-producing species Cinkov oksid Zinc oxide All food-producing species Cinkov sulfat Zinc sulphate All food-producing species Adenozin i njegovi 5-mono, 5-di i 5-trifosfati

Adenosine and its 5′-mono-, 5′-di- and 5′-triphosphates


Alanin Alanine All food-producing species Arginin Arginine All food-producing species Asparagin Asparagine All food-producing species Aspartatna kiselina Aspartic acid All food-producing species Karnitin Carnitine All food-producing species Kolin Choline All food-producing species Kimotripsin Chymotrypsin All food-producing species Citrulin Citrulline All food-producing species Cistein Cysteine All food-producing species Citidin i njegovi 5-mono, -di i 5-trifosfati

Cytidine and its 5′-mono-, 5′-di- and 5′-triphosphates


Glutamatna kiselina Glutamic acid All food-producing species Glutamin Glutamine All food-producing species Glicin Glycine All food-producing species Gvanozin i njegovi 5-mono, 5-di i 5-trifosfati

Guanosine and its 5′-mono-, 5′-di- and 5′-triphosphates


Histidin Histidine All food-producing species Hijaluronska kiselina Hyaluronic acid All food-producing species




nozin i njegovi 5′-mono, ′- di i 5′-trifosfati

Inosine and its 5′-mono-, 5′-di- and 5′-triphosphates


nozitol Inositol zoleucin Isoleucine

Leucin Leucine Lizin Lysine All food-producing species Metionin Methionine All food-producing species Ornitin Ornithine All food-producing species Orotna kiselina Orotic acid All food-producing species

epsin Pepsin All food-producing species enilalanin Phenylalanine All food-producing species rolin Proline All food-producing species erine Serine All food-producing species

Tioktna kiselina Thioctic acid All food-producing species Treonin Threonine All food-producing species Timidine Thymidine All food-producing species Tripsin Trypsin All food-producing species Triptofan Tryptophan All food-producing species Tirozin Tyrosine All food-producing species Uridine i njegovi 5′-mono, ′-di- i 5′-trifosfati

Uridine and its 5′-mono-, 5′-di- and 5′-triphosphates


Valin Valine All food-producing species olioksietilen sorbitan

monooleat Polyoxyethylene sorbitan monooleate


olioksietilen sorbitan monooleat i trioleat

Polyoxyethylene sorbitan monooleate and trioleate


4. Substances used in homeopathic veterinary medicinal products (VMP)

rmacologically e substance(s)

oatian

Pharmacologically active substance(s) - Latin


ubstances used meopathic inary medicinal ucts provided heir entration in the uct does not ed one part per housand


etni gorocvijet Adonis vernalis All food-producing species For use in homeopathic veterinary medicinal product

according to homeopathic pharmacopoeias, at concenthe products not exceeding one part per hundred only

Acqua levici All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias only

bilje Atropa belladonna All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias, at concenthe products not exceeding one part per hundred only

ica Convallaria majalis All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias, at concenthe products not exceeding one part per thousand only

ska konoplja Apocynum cannabinum

All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias, at concenthe products not exceeding one part per hundred onlyuse only

Harunga madagascariensis

All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias, at concenthe products not exceeding one part per hundred only

ica noći Selenicereus grandiflorus

All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias, at concenthe products not exceeding one part per hundred only

njačka tuja Thuja occidentalis All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias, at concenthe products not exceeding one part per hundred only

Virola sebifera All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias, at concenthe products not exceeding one part per thousand only

Ruta graveolens All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias, at concenthe products not exceeding one part per thousand onlyuse in animals from which milk is produced for humaconsumption

i kesten Aesculus hippocastanum130

All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentthe products not exceeding one part per ten only

oplja Agnus castus All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

en Ailanthus altissima All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

ni luk (crveni) Allium cepa All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

nkin korjen, ka

Arnicae radix All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding in the products not exceeding one part

only Artemisia abrotanum

All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

nčica Bellis perennis All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

n Calendula officinalis All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding in the products not exceeding one partonly

for Camphora All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentthe products not exceeding one part per hundred only

Cardiospermum halicacabum


ovi Crataegus All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

bekija, acea

Echinacea All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions theFor topical use only. For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentthe products not exceeding one part per hundred only

liptus Eucalyptus globulus All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

azija/Vidac Euphrasia officinalis All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

o Ginkgo biloba All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentthe products not exceeding one part per thousand only

eng Ginseng All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

amelis Hamamelis virginiana

All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentthe products not exceeding one part per ten only

ja kanđa Harpagophytum procumbens


časta Hypericum All food-producing species For use in homeopathic veterinary medicinal product

kavica perforatum according to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

Lachnanthes tinctoria

All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentthe products not exceeding one part per thousand only

Lobaria pulmonaria All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

Okoubaka aubrevillei


r-višnja Prunus laurocerasus All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentthe products not exceeding one part per thousand only

l palma Serenoa repens All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

vica i stričak bad

Silybum marianum All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

n europske ice

Solidago virgaurea All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

ul Syzygium cumini All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

iana Turnera diffusa All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

a imela Viscum album All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias at concentcorresponding to the mother tincture and dilutions the

rički kermes ili bojka

Phytolacca americana

All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias, at concenthe products not exceeding one part per thousand only

ki luk Urginea maritima All food-producing species For use in homeopathic veterinary medicinal productaccording to homeopathic pharmacopoeias, at concenthe products not exceeding one part per hundred onlyuse only

1 5. Substances used as food additives in foodstuffs for human consumption



1. Substances with an E number All food-producing species

Only substances approved as additives in foodstuffs for human consumption, with the exception of preservatives listed in the Ordinance on additives4

6. Substances of vegetable origin


Pharmacologically active substance(s) - Latin


Aloj gel i ekstrakt cijelog lista aloje

Aloe vera gel and whole leaf extract of Aloe vera


Aloji, barbadoški i kapski, njihovi standardizirani ekstrakti i njihovi pripravci

Aloes, Barbados and Capae, their standardised dry extract and preparations thereof


Eterično ulje anđelikina korjena

Angelicae radix aetheroleum


Aniševo eterično ulje Anisi aetheroleum All food-producing species Plod zvjezdastog anisa, standardizirani ekstrakti i njihovi pripravci

Anisi stellati fructus, standardised extracts and preparations thereof


Brđanka (cvijet i cijela biljka)

Arnica montana (arnicae flos and arnicae planta tota)


Peruanski balzam Balsamum peruvianum All food-producing species For topical use only Boldov list Boldo folium All food-producing species Nevenov cvijet Calendulae flos All food-producing species For topical use only Paprikin plod Capsici fructus acer All food-producing species Korijen kravljaka Carlinae radix All food-producing species For topical use only Kimovo eterično ulje Carvi aetheroleum All food-producing species Klinčićevo eterično ulje

Caryophylli aetheroleum All food-producing species

Ekstrakt centelina, zeleni

Centellae asiaticaer extractum


4 Article 7 of the special ordinance will transpose the provisions of European Parliament and Council Directive No 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners.

Krizantema-cvijet Chrysanthemi cinerariifolii flos


Podanak cimicifuge Cimicifugae racemosae rhizoma

All food-producing species Not for use in animals from whicmilk is produced for human consumption

Kininovčeva kora, standardizirani ekstrakti i njihovi pripravci

Cinchonae cortex, standardised extracts and preparations thereof


eterično ulje kineskog cimetovca

Cinnamomi cassiae aetheroleum


Kora kineskog cimetovca, standardizirani ekstrakti i njihovi pripravci

Cinnamomi cassiae cortex, standardised extracts and preparations thereof


eterično ulje cejlonskog cimetovca

Cinnamomi ceylanici aetheroleum


Kora cejlonskog cimetovca, standardizirani ekstrakti i njihovi pripravci

Cinnamomi ceylanici cortex, standardised extracts and preparations thereof


Eterično ulje limuna Citri aetheroleum All food-producing species Eterično ulje oštre vlaske

Citronellae aetheroleum All food-producing species

Kora kondurago kondorvine

Condurango cortex, standardised extracts and preparations thereof


Korijanderovo eterično ulje

Coriandri aetheroleum All food-producing species

Eterično ulje čempresa

Cupressi aetheroleum All food-producing species For topical use only

Purpurna rudbekija Echinacea purpurea All food-producing species For topical use only Eukaliptusovo eterično ulje

Eucalypti aetheroleum All food-producing species

Komoračevo eterično ulje

Foeniculi aetheroleum All food-producing species

Krkavinina kora, standardizirani ekstrakti i njihovi pripravci

Frangulae cortex, standardised extracts and preparations thereof


Sirištavin korjen, standardizirani ekstrakti i njihovi

Gentianae radix, standardised extracts and preparations thereof


pripravci Ginseng, standardizirani ekstrakti i njihovi pripravci

Ginseng, standardised extracts and preparations thereof


Hamamelis Hamamelis virginiana All food-producing species For topical use only Sjeme divljeg kestena

Hippocastani semen All food-producing species For topical use only

Ulje gospine trave Hyperici oleum All food-producing species For topical use only Plod borovice Juniperi fructus All food-producing species Eterično ulje lovorova lista

Lauri folii aetheroleum All food-producing species

Lovorov plod Lauri fructus All food-producing species Lavandino eterično ulje

Lavandulae aetheroleum All food-producing species For topical use only

Glavica lesperdeza

Lespedeza capitata All food-producing species

Laneno ulje Lini oleum All food-producing species Mažuran-zelen Majoranae herba All food-producing species Kamilica i njezini pripravci

Matricaria recutita and preparations thereof


Kamiličin cvijet Matricariae flos All food-producing species Ekstrakt vije lucerne Medicago sativa

extractum All food-producing species For topical use only

Matičnjakovo eterično ulje

Melissae aetheroleum All food-producing species

Matičnjakov list Melissae folium All food-producing species eterično ulje poljske metvice

Menthae arvensis aetheroleum


eterično ulje paprene metvice

Menthae piperitae aetheroleum


Stolisnikova zelen Millefolii herba All food-producing species eterično ulje muškatnog oraščića

Myristicae aetheroleum All food-producing species For use in newborn animals only

Ekstrakt turiona („mladice“ smreke)

Piceae turiones recentes extractum

All food-producing species For oral use only

Oksidacijski produkti terpentinskog ulja

Oxidation products of Terebinthinae oleum


Ekstrakt buhača Pyrethrum extract All food-producing species For topical use only Hrastova kora Quercus cortex All food-producing species Quillaja ekstrakt Quillaia saponins All food-producing species

Rabarbarin korjen, standardizirani

Rhei radix, standardised extracts and preparations


ekstrakti i njihovi pripravci

thereof

Ricinusovo ulje Ricini oleum All food-producing species For use as excipient Ružmarinovo eterično ulje

Rosmarini aetheroleum All food-producing species

Ružmarinov list Rosmarini folium


Veprina Ruscus aculeatus All food-producing species For topical use only Kaduljin list Salviae folium All food-producing species Bazgov cvijet Sambuci flos All food-producing species Sjeme crne gorušice Sinapis nigrae semen All food-producing species Sjemenka strihinovca

Strychni semen All food-producing species For oral use only at doses up to thequivalent of 0.1 mg strychnine/k

Korijen gaveza Symphyti radix All food-producing species For topical use on intact skin onlyTerpetinsko eterično ulje

Terebinthinae aetheroleum rectificatum


Balzam od ariša Terebinthinae laricina All food-producing species For topical use only Timijanovo eterično ulje

Thymi aetheroleum All food-producing species

Lipin cvijet Tiliae flos All food-producing species Kopriva Urticae herba All food-producing species

7. Anti-infectious agents




Oksalna kiselina Oxalic acid Honey bees

8. Anti-inflammatory agents




Karprofen Carprofen bovine For bovine milk only ANNEX III

LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES USED IN VMPs FOR WHICH PROVISIONAL MRLs HAVE BEEN ESTABLISHED

1. ANTIMICROBIAL AGENTS 1.2. ANTIBIOTICS 1.2.2. Macrolides

Pharmacologically active substance

English name of the

pharmacologically active substance


MRLsμg/kg

or μg/kg

Target tissues

Other provisions

Gamitromicin Gamithromycin Gamithromycin Bovines20

200 100

Fat

Liver

Kidney

Provisional MRLs expire on 1 July 2009; not for use in animals from which milk is produced for human consumption

ANNEX IV

LIST OF PROHIBITED PHARMACOLOGICALLY ACTIVE SUBSTANCES Pharmalogically active substance English name of the pharmacologically active

substance

1. Vučja stopa (Aristolochia spp.) i njezini pripravci

Aristolochia spp. and preparations thereof

2. Kloramfenikol Cholramphenicol 3. Kloroform Chloroform

4. Klorpromazin Chlorpromazine

5. Kolhicin Colchicine

6. Dapson Dapsone

7. Dimetridazol Dimetridazole

8. Metronidazol Metronidazole

9. Nitrofurani Nitrofurans (including furazolidone)

10. Ronidazol Ronidazole

ANNEX V

INFORMATION AND PARTICULARS TO BE INCLUDED IN AN APPLICATION FOR THE ESTABLISHMENT OF A MRL FOR A PHARMACOLOGICALLY

ACTIVE SUBSTANCE USED IN VMPs Administrative particulars 1. Name or corporate name and permanent address of the person submitting the application for placing the VMP on the market. 2. Name of the VMP 3. Qualitative and quantitative composition in terms of active principles, with mention of the international non-proprietary name (INN) recommended by the World Health Organisation, where such name exists 4. Manufacturing authorisation, if any. 5. VMP marketing authorisation, if any. 6. Summary of the characteristics of the VMP(s) prepared in accordance with Article 5a of a special regulation on veterinary medicinal products1

A. Safety documentation A.0. Expert report A.1. Precise identification of the substance concerned by the application for the establishment of a MRL 1.1. International non-proprietary name (INN) 1.2. International Union of Pure and Applied Chemistry Name (IUPAC) 1.3. Chemical Abstract Service (CAS) name 1.4. Classification - therapeutic - pharmcological 1.5. Synonyms and abbreviations 1.6. Structural formula 1.7. Molecular formula 1.8. Molecular weight 1.9. Degree of purity 1.10. Qualitative and quantitative composition of impurities 1.11. Description of physical properties: - fusion point - boiling point - vapour pressure - solubility in water and organic solvents expressed in g/l, with indication of temperature - density - spectra of refraction, rotation, etc. A.2. Relevant pharmacological studies 2.1. Pharmacodynamic studies

2.2. Pharmacokinetic studies A.3. Toxicological studies 3.1. Single dose toxicity (acute toxicity) 3.2. Repeated dose toxicity (chronic toxicity) 3.3. Tolerance in the target species of animal(s) 3.4. Reproductive toxicity, including teratogenicity 3.4.1. Study of the effects on reproduction 3.4.2. Embryotoxicity/fetotoxicity, including teratogenicity 3.5. Mutagenicity 3.6. Caricinogenicity A.4. Studies of other effects 4.1. Immunotoxicity 4.2. Microbiological properties of residues 4.2.1. Effects on the human gut flora 4.2.2. Effects on the micro-organisms used for industrial food processing 4.3. Observations in humans B. VMP residue documentation B.0. Expert report B.1. Precise identification of the substance concerned by the application for the establishment of a MRL The substance concerned should be identified in accordance with item A.1. However, where the application relates to one or more veterinary medicinal products, the product itself should be identified in detail, including: - qualitative and quantitative composition; - purity; - identification of the manufacturer’s batch used in the studies; comparison with the final product; - specific activity and purity of radioactive isotopes; - position of labelled atoms on the molecule. B.2. Residue studies 2.1. Pharmacokinetics (resorption, distribution, biotransformation, excretion) 2.2. Depletion of residues 2.3. Elaboration of MRLs B.3. Routine analytical methods for the detection of residues 3.1. Description of the method 3.2. Validation of the method 3.2.1. Specificity 3.2.2. Accuracy, including sensitivity 3.2.3. Precision 3.2.4. Limit of detection (LOD) 3.2.5. Limit of quantitation (LOQ) 3.2.6. Practicability and applicability under normal laboratory conditions 3.2.7. Susceptibility to interference ______________

1A special regulation on veterinary medicinal products will transpose the provisions of Directive (EC) No 2001/82, on its entry into force Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products ceased to have effect. The regulation referred to in Annex V, item 1.6. shall be adopted by 30 June 2009.

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